The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a freeze-dried plasma product to be used by the military.
The product is Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the Centre de Transfusion Sanguine des Armées, referred to in the EUA as “French FDP.”
Under the EUA, French FDP is authorized for the treatment of hemorrhage or coagulopathy in US military personnel during an emergency involving agents of military combat (eg, firearms, projectiles, and explosive devices) when plasma is not available or when the use of plasma is not practical.
The use of plasma in combat settings is severely limited by logistical and operational challenges, such as the need for refrigeration and, in the case of frozen plasma, a long thawing period.
French FDP is a powdered, freeze-dried product that can be used following reconstitution in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury.
The FDA issued the EUA for French FDP in response to a request from the US Department of Defense (DoD) and after receiving the required determination by DoD and a declaration by the Secretary of the Department of Health and Human Services.
This action is the result of a collaboration between the FDA and the DoD to prioritize development of medical products intended to help save the lives of American military personnel. The FDA outlined its approach to advancing the development of such products in a work plan developed with DoD.
“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country by expediting the development and availability of safe and effective priority medical products that are essential to the health of our military service members,” said FDA Commissioner Scott Gottlieb, MD.
“Through our collaborative program with the DoD, they’ve made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma. Granting this authorization will support access to this important product in the event it’s needed. The FDA remains deeply committed to implementing an enduring pathway to ensure that these potentially life-saving medical products are made available in the most expeditious, safe, and effective manner possible.”